DIRECT-MS funding a clinical trial to test the Best Bet Diet

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DIRECT-MS funding a clinical trial to test the Best Bet Diet

Postby Nick » Fri Sep 22, 2006 4:00 pm

Testing the Effectiveness of the Best Bet Diet for Decreasing Disease Activity in Multiple Sclerosis

Introduction Direct-MS is very pleased to be funding a rigorous clinical trial which will test the effectiveness of the Direct-MS recommended nutritional strategies, often referred to as the Best Bet Diet for MS (BBD), for affecting MS disease activity. Such research is of critical importance for determining if the recommended nutritional strategies are of value for MS and thus worth serious consideration as a therapeutic option. Recruitment for the trial began in July, 2006 and it is hoped that results will be available early in 2008.

Leaders – The chief investigator of the clinical research is Dr Jonathan O’Riordan, Consultant Neurologist and Director of Tayside MS Regional Service and Research Unit, Ninewells Hospital, Dundee, Scotland.
The principle investigator and study doctor is Dr. Pushkar S. Shah, Registrar and Research Fellow, MS Research Unit, Dept. of Neurology, Ninewells Hospital, Dundee. The MS Research Coordinator is Mrs. Sally Wilson also of Ninewells Hospital.

Ethics – The study has been approved by the Ethics Board of Ninewells Hospital. It will be conducted in accordance the European Clinical Trials Directive and associated guidelines, the International Conference on Harmonization Guidelines on Good Clinical Practice and the Principles of the Declaration of Helsinki, as well as all other national and local laws and regulations.

Goal – The main goal of the study is to compare the effectiveness of the Best Bet Diet for MS (BBD) with that of the dietary advice provided by the MS Society of Britain for decreasing MS disease activity over one year of use.

Methods – The study will involve 30 participants, all of whom have relapsing-remitting MS and EDSS disability between 0 and 3.5. Fifteen participants will be randomly assigned to the BBD and the other 15 to the dietary advice of the MS Society.

The study will last one year and each participant will have an MRI scan at baseline, 2 months, 4 months, 6 months and at 1 year. The MRI scans will measure T1 and T2 lesions as well as brain volume.
The participants will also have a complete physical and neurological examination at baseline, 6 months and 1 year. At these times disability will be measured using the EDSS (Expanded Disability Status Scale) and MSFC (MS Functional Composite) scales.

At baseline and every 4 weeks the participants will complete questionnaires including a Fatigue Severity Scale (FSS), MS Quality of Life Inventory (MSQLI) and Patient Global Assessment (PGA).

Best Bet Diet Nutritional Protocol
Eat fruits and vegetables for carbohydrates and micro-nutrients
Eat fish and skinless breast of chicken and turkey, for protein
Eat extra virgin olive oil for fats
Avoid all dairy, grains (except rice), legumes
Avoid all allergenic foods, which are identified by skin and ELISA tests.
Avoid all red meat and margarine

Supplements:
1. Grape seed extract 2 capsules/day
2. VitaminD3 2000 IU/day in summer and 4000 IU/day in winter
3. Calcium 1200 mg/day
4. Vitamin A 5000 IU/day
5. 10 grams salmon oil
6. Vitamin B-complex 50 mg/day
7. 500 mcg of B-12
8. 1 g of vitamin C
9. 400 IU of vitamin E
10. up to 750 mg of magnesium (a good Ca/Mg ratio is 2:1)
11. 25 mg of zinc
12. 1 mg of copper
13. 200 mcg of selenium
14. Manganese 20 mg/day
15. up to 5 g of evening primrose oil or borage oil
16. 4 capsules of acidophilus
17. 4 capsules of enzymes
18. 500 - 1000 mg of Lecithin.
19. Ginkgo biloba 120 mg/day
20. Co-enzyme Q10 60 mg/day.


MS Society of Britain Dietary Advice –
1. Five portions of fruit or vegetables everyday including one portion of dark green, leafy vegetables.
2. Use polyunsaturated margarine and oils such as sunflower oil or corn oil, instead of saturated fat such as lard and butter.
3. Grill, Bake, steam or poach food instead of frying.
4. Choose lean cuts of meat. Avoid sausages, pates and beefburgers, as they are often high in saturated fat.
5. Avoid too much saturated fat and hydrogenated vegetable oil in foods like pastry, cakes and chocolate.
6. Eat at least two portions of fish a week, one of which should be oily fish like mackerel, pilchards, salmon or sardines.
7. Use low fat dairy products such as skimmed milk, low-fat yoghurt or low fat cheeses.
8. Eat whole meal bread and whole grain cereals.
9. Drink six to eight cups of fluid daily (about 1.5 litres). Don’t rely on high-caffeine drinks, such as coffee, tea and cola.

Monitoring Dietary Compliance – The participants will complete food diaries every 3 months and, in-between the visits to the clinic, subjects will be given reminders via phone and letters. They will also have daily access to the research unit for dietary advice.

Results – The effects on MS disease activity after one year will be assessed through the measured changes in disability scores, brain volume and lesion load. An assessment of symptom control and quality of life will be obtained from the completed questionnaires. The various results from those participants on the BBD will be statistically compared with the results from those following the dietary advice of the MS Society to determine if the BBD has a measurable positive effect on MS disease activity.

Discussion – This clinical trial is basically a “Phase I/II” trial and will determine if the BBD has a measurable effect on MS disease activity and if such dietary research can be accomplished in a scientifically acceptable manner. If positive results are obtained, a larger trial, involving up to 100 participants in each arm, will be necessary to confirm the positive effect of the BBD and to allow a better assessment of the strength of that effect.

Cheers
Nick
Last edited by Nick on Wed Sep 27, 2006 11:38 am, edited 1 time in total.
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Postby mrhodes40 » Fri Sep 22, 2006 8:41 pm

I am pleased this will finally take place, though I suspect the findings will be inconclusive but I can hope to be proven wrong certainly!
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Re: DIRECT-MS clinical trial to test the Best Bet Diet

Postby NHE » Sat Sep 23, 2006 6:12 am

Nick wrote:Supplements:
1. Grape seed extract 2 capsules/day

I was surprised at the inclusion of grape seed extract especially considering that some researchers have found it to promote interferon-gamma in vitro. Are there other effects of grape seed extract which counter balance this potential increase in interferon-gama? If one is looking for a good antioxidant I would think that epigallocatechin gallate (EGCG) from green tea or r-lipoic acid might be better choices as both of these have a general anti-inflammatory effect through their inhibition of NF-kB (curcumin might also be a good choice). As I have a strong interest in the effects of different antioxidants, I look forward to reading your thoughts on this.
mrhodes40 wrote:I suspect the findings will be inconclusive but I can hope to be proven wrong certainly!

I have a similar feelings about the proposed outcome as well. It seems that there might be a larger treatment effect if the comparison was between the Best Bet Diet and a normal healthy diet (whatever that is) or between MS patients who agree to make no special alterations to their diet. This study seems like it's comparing treatment A to treatment B and not to a real nul placebo though it does look like it will provide some control over any potential variability in the diet of the "control" group.

Lastly, please don't take my questions/observations as being critical. They're not intended as such. It's great to see a controlled study being done on the effects of diet especially since my own neuro's opinion was that special changes to the diet weren't necessary. I haven't followed that advice though and one of the biggest changes I've made to my own diet, besides adding various supplements, was to eliminate partially hydrogenated fats. A change for the better for anyone in my opinion.

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Postby Muu » Wed Sep 27, 2006 3:03 am

I will watch this space with great interest.
I am following my own version of the best bet diet - I say my own version as I take some but not all of the supplements suggested and steer clear of dairy, wheat, gluten grains and sadly legumes too (they're always considered so healthy!) and try to eat more fish and less red meat. Personally that's about manageable for me.
My neuro was not dismissive but did state (accurately) that there was no scientific evidence to support the BBD. My own theory is that it is unlikely that anyone would stump up the funding for this food related research whereas drug companies have a vested interest in funding a trial that may result in their drug being identified as beneficial. Also, it's too easy to slip on any diet rather than a requirement to take x mg of y a day. Reading that funding is available is a pleasant surprise.
Personally speaking the BBD makes me feel better than before and helps keep the weight off. Whether that's just coincidental to the unpredictable nature of ms or that it makes me feel that I have regain some control i don't know. I do know that I couldn't enjoy bread, butter and a smelly French cheese now despite the occasional hankering for them. Pass the rice cakes!!
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Re: DIRECT-MS clinical trial to test the Best Bet Diet

Postby Nick » Wed Sep 27, 2006 12:09 pm

Hi NHE

NHE wrote:1. Grape seed extract 2 capsules/day
I was surprised at the inclusion of grape seed extract especially considering that some researchers have found it to promote interferon-gamma in vitro. Are there other effects of grape seed extract which counter balance this potential increase in interferon-gama? If one is looking for a good antioxidant I would think that epigallocatechin gallate (EGCG) from green tea or r-lipoic acid might be better choices as both of these have a general anti-inflammatory effect through their inhibition of NF-kB (curcumin might also be a good choice). As I have a strong interest in the effects of different antioxidants, I look forward to reading your thoughts on this.


I don't know why lipoic acid is not included since we recommend it on our website. The use of grape seed extract I believe, is due to the ability of it to pass through the brain blood barrier and do its thing. I knew what this was ten years ago when I was into the research angle but its virtue escapes me now.

NHE wrote:I have a similar feelings about the proposed outcome as well. It seems that there might be a larger treatment effect if the comparison was between the Best Bet Diet and a normal healthy diet (whatever that is) or between MS patients who agree to make no special alterations to their diet. This study seems like it's comparing treatment A to treatment B and not to a real nul placebo though it does look like it will provide some control over any potential variability in the diet of the "control" group.


We consider the MS Society recommended diet to be as causal as a normal diet and thus don't consider the comparison to be devoid of a placebo. Furthermore if our trial demonstrates a substantive difference than the MS Society recommended diet than then will be compelled to alter their recommended diet accordingly.

NHE wrote:Lastly, please don't take my questions/observations as being critical. They're not intended as such. It's great to see a controlled study being done on the effects of diet especially since my own neuro's opinion was that special changes to the diet weren't necessary. I haven't followed that advice though and one of the biggest changes I've made to my own diet, besides adding various supplements, was to eliminate partially hydrogenated fats. A change for the better for anyone in my opinion.

NHE


Not at all. Thank you for your input.

Cheers
Nick
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